510(k) · Cleared
ClearedSTERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Sterilization Products (Asp) · FRC Indicator, Biological Sterilization Process
Cleared on Jan 23, 2020 as substantially equivalent to K182404 (Advanced Sterilization Products (Asp), 2018) after a 178-day review. Its family tree reaches back 10 generations to 2002. 1 later device descends from it.
- Decided
- Jan 23, 2020
- Review
- 178 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K994055 (2002). 18 ancestors in all, the oldest K900771 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK994055 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2002 · Recalled
- 6 generations between
- 3 generations backK152060 3M Attest Rapid Readout Biological Indicator 12953M Company · 2015
- 2 generations backK170039 STERRAD VELOCITY Biological Indictator and ReaderAdvanced Sterilization Products (Asp) · 2017
- 1 generation backK182404 STERRAD VELOCITY Biological IndicatorAdvanced Sterilization Products (Asp) · 2018
- This deviceK192025 STERRAD VELOCITY Biological Indicator/Process Challenge Device and…Advanced Sterilization Products (Asp) · 2020
- Descendant · cites it directly · 0 of its ownK234084 STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE®…Advanced Sterilization Products, Inc. · 2024
Show all 10 generations
- Root · 10 generations backK994055 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2002 · Recalled
- 9 generations backK031226 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2003 · Recalled
- 8 generations backK071014 Modification to Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2007
- 7 generations backK102884 Sterrad Cyclesure 24 Biological IndicatorAdvanced Sterilization Products · 2011
- 6 generations backK111375 Sterrad (R) Cyclesure (R) 24 Biological IndicatorAdvanced Sterilization Products · 2012
- 5 generations backK123017 Sterrad Cyclesure 24 Biological Indicator Model 14324Advanced Sterilization Products · 2012
- 4 generations backK140392 3M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader3M Company · 2014
- 3 generations backK152060 3M Attest Rapid Readout Biological Indicator 12953M Company · 2015
- 2 generations backK170039 STERRAD VELOCITY Biological Indictator and ReaderAdvanced Sterilization Products (Asp) · 2017
- 1 generation backK182404 STERRAD VELOCITY Biological IndicatorAdvanced Sterilization Products (Asp) · 2018
- This deviceK192025 STERRAD VELOCITY Biological Indicator/Process Challenge Device and…Advanced Sterilization Products (Asp) · 2020
Most influential descendants
Showing 1 of 1 · See all- K234084STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator…Advanced Sterilization Products, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K994055 | Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2002 | 1 |
| −9 | K031226 | Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2003 | 1 |
| −8 | K071014 | Modification to Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2007 | — |
| −7 | K102884 | Sterrad Cyclesure 24 Biological Indicator | Advanced Sterilization Products | 2011 | — |
| −6 | K111375 | Sterrad (R) Cyclesure (R) 24 Biological Indicator | Advanced Sterilization Products | 2012 | — |
| −5 | K123017 | Sterrad Cyclesure 24 Biological Indicator Model 14324 | Advanced Sterilization Products | 2012 | — |
| −4 | K140392 | 3M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader | 3M Company | 2014 | — |
| −3 | K152060 | 3M Attest Rapid Readout Biological Indicator 1295 | 3M Company | 2015 | — |
| −2 | K170039 | STERRAD VELOCITY Biological Indictator and Reader | Advanced Sterilization Products (Asp) | 2017 | — |
| −1 | K182404 | STERRAD VELOCITY Biological Indicator | Advanced Sterilization Products (Asp) | 2018 | — |
| 0 (this device) | K192025 | STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader | Advanced Sterilization Products (Asp) | 2020 | — |
| +1 | K234084 | STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical… | Advanced Sterilization Products, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRC device
- #1 K250044 Celerity 5 HP Biological Indicator (LCB052)…score 14.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K182404 | STERRAD VELOCITY Biological IndicatorSummary page 4…Class: Class II Product Code: FRC CFR Section: 21 CFR 880.2800 Predicate Device Predicate Device: STERRAD VELOCITY Biological Indicator, K182404 cleared December 27, 2018 Description STERRAD VELOCITY Biological Indicator/Process Challenge Device The STERRAD VELOCITY Biol… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K234084 | STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator… | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 4 of the 18 ancestors have a recall of any class.
- Of its descendants, K234084 (Advanced Sterilization Products, Inc., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · FRC
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRC
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRC
8so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRC
9in 2025
MAUDE reports naming product code FRC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 83 | 0 | 100 |
| 2008 | 1 | — | 0 | 60 |
| 2009 | 6 | 183 | 1 | 45 |
| 2010 | 4 | 165 | 0 | 57 |
| 2011 | 6 | 118 | 0 | 37 |
| 2012 | 9 | 178 | 2 | 46 |
| 2013 | 4 | 260 | 2 | 39 |
| 2014 | 13 | 174 | 0 | 51 |
| 2015 | 3 | 130 | 0 | 182 |
| 2016 | 2 | — | 0 | 482 |
| 2017 | 10 | 130 | 0 | 182 |
| 2018 | 18 | 97 | 0 | 22 |
| 2019 | 5 | 88 | 0 | 30 |
| 2020 | 10 | 150 | 0 | 16 |
| 2021 | 5 | 107 | 0 | 10 |
| 2022 | 5 | 193 | 4 | 9 |
| 2023 | 6 | 190 | 1 | 20 |
| 2024 | 8 | 105 | 0 | 22 |
| 2025 | 6 | 29 | 0 | 9 |
| 2026 | 1 | — | 8 | — |
What is it indicated for?
STERRAD VELOCITY® Biological Indicator/Process Challenge Device, in conjunction with the STERRAD VELOCITY Reader, is intended to be used as a standard method for frequent monitoring and periodic testing of the following STERRAD Sterilization Systems:
• STERRAD® I00NX (STANDARD, FLEX, EXPRESS, and DUO Cycles) with and without ALLClear® Technology
• STERRAD NX® (STANDARD and ADVANCED Cycles) with and without ALLClear® Technology
• STERRAD® 1 00S
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192025: STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192025
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026